MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE LUX M9000 LS; DENTAL HANDPIECE

Model Number M9000 LS

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Burn(s) (1757)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Prior to the repair the instrument has been evaluated.Turning the inserted tool by hand showed that the ball bearings have been running very gritty.A short test run showed that the heat up was reproducible.After disassembling of the instruments head it got visible that the ball bearings have been falling apart and no lubrication was inside the head.It was noticeable that the turbine which is made out of an aluminum alloy was covered with a black layer.This layer turned out to be a kind of strong oxidation which suggests that very strong cleaning agents get used for the reprocessing which are not suitable for the product.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: warning: hazards for the care provider and the patient.In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held.Do not use further and notify service.Technical condition a damaged device or components could injure patients, users and third parties.Only operate devices or components if they are undamaged on the outside.Check that the device is working properly and is in satisfactory condition before each use.If there are any sites of breakage or clearly recognised changes on the surface, the parts must be checked by the service.Safety checks may only be performed by trained service personnel.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions, damage, irregular noise, excessive vibration, untypical heating, and no firm seating of the grinder or cutter in the instrument.Observe the following instructions in order to guarantee optimum functioning and prevent material damage: service the medical device with care products and systems regularly as described in the instructions for use.Kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check.Define the service interval depending on the frequency of use.

Event Description

When the instrument was sent in for repair it was just stated that it overheats and that several patients suffered burns.It was not possible to get further information from user.

• Brand Name: MASTERTORQUE LUX M9000 LS
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 12538851
• MDR Text Key: 273571921
• Report Number: 3003637274-2021-00034
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M9000 LS
• Device Catalogue Number: 1.008.5400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1